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The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2015 by Yong Min Ahn, Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01654640
First Posted: August 1, 2012
Last Update Posted: December 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital
July 16, 2012
August 1, 2012
December 8, 2015
July 2012
April 2016   (Final data collection date for primary outcome measure)
change of weight [ Time Frame: baseline, 12 weeks, 24 weeks ]
change of weight after 12-week, 24-week. calculation; (weight of 12-week - weight of baseline)/baseline weight (weight of 24-week - weight of baseline)/baseline weight
Same as current
Complete list of historical versions of study NCT01654640 on ClinicalTrials.gov Archive Site
  • Positive and Negative Symptom Scale(PANSS) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)
  • MADRS(montgomery asberg depression rating scale) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)
  • Clinical Global Impression-severity(CGI-S) [ Time Frame: baseline, 6 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)
  • Clinical Global Impression-improvement(CGI-I) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)
  • Beck's Depression Inventory(BDI) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)
  • Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)
  • World Health Organization Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)
  • Short form(36) Health survey (SF-36) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)
  • abdominal fat amount CT [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 12-week, 24-week
  • change of prevalence of metabolic syndrome [ Time Frame: baseline, 12 weeks, 24 weeks ]
    waist circumference, blood pressure cholesterol,triglyceride, HDL-cholesterol,fasting glucose
Same as current
Not Provided
Not Provided
 
The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
The purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine.
In this study, the investigators are going to examine the effect of metformin on obesity and metabolic disturbance in patients with schizophrenia who have taken clozapine.The metformin 500mg will be administrated per oral twice a day for 24 weeks and for control group, placebo will be given same route and process.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Metformin
    metformin 500mg p.o. bid for 24 weeks
    Other Name: Diabex
  • Drug: Placebo (for metformin)
    placebo 1T bid
    Other Name: placebo
  • Experimental: Metformin group
    Metformin 500mg 1 tablet p.o. bid
    Intervention: Drug: Metformin
  • Placebo Comparator: Placebo group
    1 tablet p.o. bid
    Intervention: Drug: Placebo (for metformin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
June 2016
April 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: 18 ~ 65
  • Patient with schizophrenia according to DSM-IV criteria
  • Patient have signed on the informed consent, and well understood the objective and procedure of this study.
  • Patient taking clozapine 3months or more
  • Patient increased in weight more than 10 % of that of before antipsychotics use

Exclusion Criteria:

  • Patient taking other antipsychotics with clozapine
  • Patient in treatment of diabetes
  • Patient in treatment of dyslipidemia
  • Allergy or hypersensitivity to metformin
  • Pregnant or breast-feeding female patient.
  • Patient with severe medical condition
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01654640
DW_Metformin
Yes
Not Provided
Not Provided
Yong Min Ahn, Seoul National University Hospital
Seoul National University Hospital
Daewoong Pharmaceutical Co. LTD.
Principal Investigator: Yong Min Ahn, MD, PhD Seoul National University Hospital
Seoul National University Hospital
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP